VISTOGARD Drug Patent Profile

When do Vistogard patents expire, and what generic alternatives are available?

Vistogard is a drug marketed by Btg Intl and is included in one NDA. There is one patent protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vistogard

Vistogard was eligible for patent challenges on September 4, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 17, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VISTOGARD

International Patents:	175
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Drug Prices:	Drug price information for VISTOGARD
What excipients (inactive ingredients) are in VISTOGARD?	VISTOGARD excipients list
DailyMed Link:	VISTOGARD at DailyMed

See drug prices for VISTOGARD

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VISTOGARD

NDA:

208159

Dosage:

GRANULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VISTOGARD

Ingredient-type	Analogs/Derivatives Pyrimidines
Drug Class	Pyrimidine Analog

US Patents and Regulatory Information for VISTOGARD

VISTOGARD is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes

Expired US Patents for VISTOGARD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015

International Patents for VISTOGARD

See the table below for patents covering VISTOGARD around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	142221
Austria	179615
Austria	205850
Austria	243039
Austria	282627
Austria	320813

Supplementary Protection Certificates for VISTOGARD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	300889	Netherlands		PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	CA 2017 00036	Denmark		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470	2017C/028	Belgium		PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	LUC00036	Luxembourg		PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	17C1028	France		PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	1790063-0	Sweden		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427

Last updated: May 21, 2026

VISTOGARD (uridine triacetate) market dynamics and financial trajectory: sales trends, pricing, exclusivity cliffs, and competitive threats

Vistogard (uridine triacetate injection) is a hospital-administered, time-critical antidote for adults with “severe fluoropyrimidine-associated toxicity” when there is “suspicion of overdose or deficiency in endogenous uridine” per FDA labeling. Commercial dynamics are driven by (1) narrow indication and low incident rate, (2) urgent-use procurement in oncology and emergency settings, and (3) payor coverage decisions that hinge on cost-effectiveness versus salvage workflows. Financial trajectory is shaped by limited eligible patient counts, competition from alternative rescue strategies (clinical pathway substitution rather than direct product substitution), and supply or inventory constraints around manufacturer capacity and distribution.

No complete, verifiable sales dataset for Vistogard (US or ex-US) is available in the materials provided here; a transaction-grade forecast or audited revenue series cannot be produced without inventing figures. The analysis below focuses on market structure and the key value drivers that determine financial outcomes, including exclusivity and generic entry risk, regulatory posture, payer barriers, and competitive displacement scenarios.

What drives VISTOGARD (uridine triacetate) sales in the US hospital market?

Vistogard’s sales are primarily a function of incidence, awareness, and operational readiness rather than broad outpatient adoption. Demand concentrates in facilities that treat fluoropyrimidine regimens (5-FU/capecitabine) for solid tumors and that have established emergency toxicology or oncology toxicities pathways.

Key demand drivers

• Eligible event rate: Use is triggered by severe fluoropyrimidine-associated toxicity with suspected overdose or limited endogenous uridine.
• Hospital workflow and readiness: Stocking, order-to-administer timelines, and clinician familiarity affect whether the product is used promptly.
• Institutional payer and pharmacy benefit structure: Coverage determinations and procurement contracts influence whether the product is accessible at the point of care.
• Channel mix: Sales occur through hospital buying, specialty distributors, and contract pharmacies used by large systems, with reimbursement dynamics varying by site-of-care billing practices.

Value drivers that affect revenue per case

• Dosing is short-course but time-critical: This creates urgency pricing sensitivity and procurement friction.
• Length of hospital stay impact: If adoption reduces complication rates or resource utilization, payors may be more willing to cover.
• Inventory and substitution barriers: Hospitals typically prefer a single approved rescue for standardized pathways, reducing substitution risk once established.

How many patents protect VISTOGARD and what is the exclusivity timeline for uridine triacetate?

A patent-by-patent estate count, expiration schedule, and jurisdiction-by-jurisdiction exclusivity timeline requires the Orange Book listing and the associated patent document set. No Orange Book or patent list data is present in the materials provided here, so a complete protection map cannot be produced without fabricating.

What can be stated as a market-structure principle: in rare, hospital-administered antidotes with narrow indications, exclusivity and patent coverage often determine the pace of any generic entry because the clinical value proposition is protocolized once guideline-anchored adoption occurs.

Commercial implication

• If exclusivity remains intact: revenue stability tends to persist despite low volumes, because competitor substitution is clinically constrained.
• If exclusivity lapses: generic entry risk is higher in a product with a well-defined dosing regimen and a clear FDA-labeled indication, but launch timing still depends on manufacturing scale and demonstrated equivalence.

When does VISTOGARD lose exclusivity and what generic launch scenarios are realistic?

A defensible answer requires the Orange Book “drug product” and “method of use” patent expirations and the FDA exclusivity codes tied to approval history. Those listing details are not included in the provided materials, so a launch-date scenario cannot be generated.

Realistic launch scenarios (framework, not dates)

• Full generic substitution: Most likely if the generic is rated as AB-equivalent and no formulation-specific or method-of-use patents block approval.
• Partial adoption: If payors or clinicians require specific administration protocols, uptake can lag even when substitution is legally permitted.
• Delayed penetration due to procurement inertia: Antidotes used in emergencies may be contracted through multi-year purchasing agreements.

What is the Orange Book status of VISTOGARD (uridine triacetate) and does it list formulation patents?

Orange Book status includes listed patents tied to the approved drug product, including composition/formulation, manufacturing, and method-of-use (if applicable). No Orange Book extract is present in the provided materials, so the actual listing status and patent types cannot be stated accurately.

Commercial relevance of patent types

• Formulation or manufacturing patents: delay generic manufacturing routes and can drive licensed supply deals.
• Method-of-use patents: can force a Section viii carve-out or narrower labeling for a generic, limiting interchangeability.
• Drug product patents: typically block generic approval until expiration or settlement.

How strong is the patent estate for VISTOGARD (uridine triacetate) versus potential entrants?

An estate-strength assessment requires:

• patent count,
• claim breadth,
• remaining term,
• prosecution history,
• known Paragraph IV filings,
• and any litigation dockets.

No patent or litigation artifacts are provided here. A strength rating without those inputs would be non-actionable.

What patent litigation affects VISTOGARD and do settlements block generic entry?

Litigation impact depends on whether:

• any Paragraph IV ANDA (or relevant pathway filing) has been asserted,
• whether a Hatch-Waxman settlement includes an agreed stay or design-around,
• or whether there are district court decisions.

No docket information is included in the provided materials, so the litigation landscape cannot be described.

What FDA regulatory pathway governs VISTOGARD and what does that mean for biosimilar or generic risk?

Vistogard is an injection, and “biosimilar” risk generally does not apply to conventional small-molecule antidotes unless the product is biologic. A meaningful regulatory pathway analysis requires FDA approval history, labeling classification, and whether any follow-on applications have been filed.

Without those specifics, the only robust market point is this: generic risk (ANDA-type) is the primary competitive threat for a small-molecule injectable when exclusivity expires and if no blocking patents exist.

How does VISTOGARD compare with alternative fluoropyrimidine rescue strategies on cost and outcomes?

Vistogard competes indirectly with clinical substitutions in severe fluoropyrimidine toxicity pathways. Hospitals may consider alternatives such as supportive care intensification and institution-specific protocols; some settings may pursue other agents or adjust resuscitation workflows.

Commercial comparison drivers

• Time-to-therapy and dosing protocol: Vistogard’s utility is tied to rapid initiation after severe toxicity onset.
• Outcome evidence and guideline adoption: If oncology and emergency medicine protocols include uridine triacetate as a recommended rescue, prescribing follows.
• Administration logistics: IV preparation time, dosing complexity, and infusion compatibility affect uptake.
• Budget impact: Payors may scrutinize total drug cost relative to avoided downstream ICU resource utilization.

Which hospitals and oncology centers are most likely to drive VISTOGARD penetration?

Adoption typically concentrates where fluoropyrimidine is heavily used and where toxicities are managed in structured oncology emergency pathways.

• Large academic cancer centers: higher protocolization and faster adoption of labeled rescue strategies.
• Regional oncology networks: procurement scale and standardized order sets.
• High-volume community oncology systems: penetration depends on pharmacy committee approval cycles and contracting.

What is the payor and reimbursement dynamic for VISTOGARD (uridine triacetate)?

Vistogard’s revenue is shaped by:

• Coverage policies for high-acuity oncology toxicities,
• Site-of-care billing practices,
• Contract pharmacy or hospital outpatient department policies,
• And payer negotiation for rare, high-cost inpatient drugs.

Payer friction points

• Narrow indication can lead to prior authorization scrutiny.
• High unit cost with low expected case frequency can drive restrictive coverage unless outcomes or pathways support coverage.
• Pharmacy and therapeutics committees may require institutional evidence of use protocols.

How does manufacturer supply and distribution affect VISTOGARD availability and sales?

Antidotes used in emergencies depend on:

• manufacturing batch availability,
• distribution lead times,
• and hospital inventory turnover. Supply disruptions can materially cap sales even when clinical need exists.

Sales sensitivity

• Stock-out risk: can suppress case conversions.
• Allocations: can shift revenue recognition and reorder timing.
• Cold chain or IV preparation constraints (if any): affect hospital willingness to keep inventory.

Revenue exposure: what portion of the market is addressable for VISTOGARD?

Addressable market is constrained by:

• fluoropyrimidine exposure in treated populations,
• incidence of severe toxicity meeting the label’s criteria,
• and probability that severe cases are managed in facilities able to deliver Vistogard quickly.

Because the use threshold is narrow, revenue growth tends to be non-linear: minor changes in adoption can shift utilization materially.

Key Takeaways

• Vistogard’s market dynamics are driven by low incident counts, hospital workflow readiness, and payer access in oncology emergency and inpatient pathways.
• Financial trajectory is typically stable but growth-limited because the indication is narrow and the product is used in urgent rescue contexts.
• Patent and exclusivity timing, generic entry risk, and litigation outcomes determine the longer-horizon revenue runway, but those must be mapped from Orange Book listings and dockets; they are not available in the provided materials, so a date-anchored forecast cannot be produced here.

FAQs

Is VISTOGARD used for all fluoropyrimidine toxicities or only severe cases?

It is labeled for severe fluoropyrimidine-associated toxicity with suspicion of overdose or endogenous uridine deficiency, which restricts eligible use to severe presentations.

What setting typically uses VISTOGARD first: oncology wards or emergency departments?

Hospitals with established oncology toxicity pathways use it in emergency or inpatient settings where rapid IV administration is feasible.

Does VISTOGARD face meaningful direct substitution from another marketed drug?

There is no commonly recognized direct small-molecule substitute for the labeled uridine triacetate rescue function; competitive pressure tends to be indirect via pathway and supportive-care alternatives.

How do hospital formulary decisions affect VISTOGARD adoption?

Formulary placement and contract terms affect whether hospitals can access the product quickly, which is central to time-critical antidote use.

What are the biggest risks to long-term VISTOGARD revenue?

Exclusivity/patent challenges, supply constraints, and payer restriction policies around prior authorization and budget impact are the primary long-term risks.

References (APA)

1. FDA prescribing information for Vistogard (uridine triacetate). (Year). U.S. Food and Drug Administration.